Validation Rule Suggestions

ADaMiG (v1.0 and 1.1) is strictly in favour of restricting the allowed scenarios for creating new variables. While the various fragments - prefixed radicals (e.g. 'WA' used for references to wash-out) and suffixes *FL, *DT etc - suggest this should probably not even be a warning, it would be great of p21 could identify all variables not in ADSL and not named in one of ADaMiG, OCCDS or TTE.

As per FDA study technical conformance guide:

3.3.3 Dataset Column Length

The allotted length for each column containing character (text) data should be set to the maximum length of the variable used across all datasets in the study except for suppqual datasets. For suppqual datasets, the allotted length for each column containing character (text) data should be set to the maximum length of the variable used in the individual dataset.

Hi P21 Team,

May I know, if the validation rules have been updated for EC-EX Domain Derivation.
Or by when would these rules be available in the Enterprise Version at least.

This suggestion is a change to the following rule in the SEND 3.0 (FDA).xml rule set:

The validation rule as implemented in Pinnacle 21 is incomplete for the MI domain. It doesn’t appear to include “per Finding Result” in its validation test. These domains should have a single record with the same USUBJID, --SPEC, and --ORRES.

Currently, Pinnacle only checks for non-ASCII data in VLM fields (e.g –TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). What is your opinion about extending the rule to check ALL data fields for non-ascii characters? Can this be implemented in community version?

Hey guys,

The Rules repository is down just when I was upadting the documentation to one of my tools.

I wanted to make the link between each of my checks and the OpenCDISC checks... Timing is a b****, :-).

When is this expected to be up again?

Best wishes,

Dirk

Pinnacle Community combines FDA rules FDAN014 and FDAN015, and assigns the lower severity of warning, where rule FDAN014 is listed as an ERROR by the FDA for the domains of TS, TX, and DM.

Pinnacle Community combines FDA rules FDAN018 and FDAN019, and assigns the lower severity of warning, where rule FDAN019 is listed as an ERROR by the FDA for the TS domain.

Pinnacle Community calls FDAN031 a Notice; the FDA rule set classifies it as a Warning.

Pinnacle Community calls FDAN055 a Notice; the FDA rule set classifies it as a Warning.

The tool warns about imputed values for these two variables.  When POOLID is used instead of USUBJID for FW records (which is very common), the tool doesn't find the RFSTDTC and thinks the value is, therefore, imputed.